Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,006
- 试验地点
- 16
- 主要终点
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
研究概览
简要总结
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
详细描述
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
- •A male or female between, and including, 18 - 64 years of age at the time of vaccination.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must have a negative pregnancy test, practice adequate contraception for 30 days prior to vaccination, and continue such precautions for 2 months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose
- •Administration of a vaccine not foreseen by the study protocol from 30 days before vaccination, up to 21 days after vaccination.
- •History of hypersensitivity to a previous dose of influenza vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s)
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Confirmed influenza infection within a year preceding the study start.
- •Administration of an influenza vaccine within a year preceding the study start.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- •Pregnant or lactating female.
- •Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- •Acute disease at the time of enrolment.
- •History of chronic alcohol consumption and/or drug abuse.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- •History of administration of experimental/licensed vaccine containing squalene and/or tocopherol within the last 12 months.
研究组 & 干预措施
GSK1247446A 1 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza Vaccine GSK1247446A - 4 different formulations (Biological)
GSK1247446A 2 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza Vaccine GSK1247446A - 4 different formulations (Biological)
GSK1247446A 3 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza Vaccine GSK1247446A - 4 different formulations (Biological)
GSK1247446A 4 Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Influenza Vaccine GSK1247446A - 4 different formulations (Biological)
Fluarix Group
Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
干预措施: Fluarix™ (Biological)
结局指标
主要结局
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
时间窗: At Days 0, 21 and 180
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (SOLO), A/Wisconsin (WISC) and B/Malaysia (MALA). The seropositivity cut-off assay was 1:10. The results for Day 0 and Day 21 are the primary efficacy variables.
次要结局
- Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.(At Days 21 and 180)
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.(At Days 0, 21 and 180)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(During the 21-day (Days 0-20) post vaccination period)
- Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.(At Days 0, 21 and 180)
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.(At Days 0, 21 and 180)
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.(At Days 0 and 21)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 7-day (Days 0-6) post vaccination period)
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.(At Days 21 and 180)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day (Days 0-6) post vaccination period)
- Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs).(From Day 0 to Day 180)
- Number of Subjects With Serious Adverse Events (SAEs).(From Day 0 to Day 180)